On April 21, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women’s health and prostate cancer, reported that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer (Press release, Myovant Sciences, APR 21, 2020, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-submits-new-drug-application-nda-fda-once-daily [SID1234556469]). Myovant also announced that it expects to submit its NDA for once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding associated with uterine fibroids in May 2020.

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TWEET THIS: "The submission of our NDA for prostate cancer is a major step towards providing a one pill, once a day potential new treatment option for men with advanced prostate cancer," said Lynn Seely, M.D., chief executive officer of Myovant Sciences. "Based on the robust efficacy and safety data from the Phase 3 HERO study, we believe relugolix, if approved, could provide men an important oral alternative to leuprolide injections, the current standard of care."

The NDA submission is supported by positive results from the Phase 3 HERO study, a randomized pivotal study comparing relugolix versus leuprolide acetate. Relugolix met the primary efficacy endpoint with 96.7% of men achieving sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks. Six key secondary endpoints demonstrated superiority to leuprolide acetate, including sustained testosterone suppression to castrate levels through 48 weeks, rapid suppression of testosterone at Day 4 and at Day 15, profound suppression of testosterone (< 20 ng/dL) at Day 15, rapid suppression of prostate-specific antigen (PSA) at Day 15, and suppression of follicle-stimulating hormone (FSH) at Week 24 (all p-values < 0.0001). The overall incidence of adverse events in the relugolix and leuprolide acetate groups was comparable (92.9% vs. 93.5%, respectively). Major adverse cardiovascular events were reported in 2.9% of men in the relugolix group versus 6.2% of men in the leuprolide acetate group. These events included non-fatal myocardial infarction, non-fatal stroke, and all-cause mortality.

"We made the decision to prioritize this NDA submission and potentially accelerate the availability of an oral treatment option for men with advanced prostate cancer," said Juan Camilo Arjona, M.D., chief medical officer of Myovant Sciences. "This is of particular importance in the current environment and for the foreseeable future due to COVID-19 and the need for men with advanced prostate cancer to go to a clinic to receive injections in person."

About the Phase 3 HERO Program in Advanced Prostate Cancer
Myovant’s Phase 3 clinical program for advanced prostate cancer consisted of a randomized, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix in men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Men enrolled in the study were randomized 2:1 to receive a single loading dose of relugolix 360 mg followed by relugolix 120 mg once daily, or to treatment with leuprolide acetate 3-month depot injection, respectively.

Approximately 1,100 men are planned to be enrolled in this study, including approximately 430 men with metastatic prostate cancer to support the analysis of a secondary endpoint of castration resistance-free survival, data which are expected in the third quarter of 2020, and 90 Chinese men (enrolled in China and Taiwan) to support registration in China.

About Prostate Cancer
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34% of deaths in men with prostate cancer in the U.S. Approximately three million men in the U.S. are currently living with prostate cancer, and approximately 170,000 men are estimated to be newly diagnosed in 2019. Advanced prostate cancer is prostate cancer that has spread or come back after treatment and may include men with biochemical recurrence (rising PSA in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Treatment for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels. GnRH receptor agonists, such as leuprolide acetate, or slow-release injections are the current standard of care for androgen deprivation therapy. However, GnRH receptor agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial rise in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone production, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Myovant is developing relugolix as a monotherapy tablet (120 mg once daily) for men with advanced prostate cancer. Myovant is also developing a relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with uterine fibroids and for women with endometriosis.

On April 21, 2020 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that the U.S. Patent and Trademark Office has issued a composition of matter patent for cosibelimab (formerly referred to as CK-301), Checkpoint’s high affinity, fully-human IgG1 monoclonal antibody that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. U.S. Patent No. 10,590,199 specifically covers the antibody, cosibelimab, or a fragment thereof, providing protection through at least May 2038, exclusive of any additional patent-term extensions that might become available (Press release, Checkpoint Therapeutics, APR 21, 2020, View Source [SID1234556468]).

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Cosibelimab is currently being studied in an ongoing, multicenter, registration-enabling Phase 1 clinical trial intended to support a potential Biologics License Application ("BLA") submission for the initial indication of metastatic cutaneous squamous cell carcinoma ("CSCC"). Earlier this year, Checkpoint announced that the U.S. Food and Drug Administration had confirmed the registration submission pathway for cosibelimab in CSCC based on the ongoing clinical trial, which is over one-third enrolled. Cosibelimab is potentially differentiated from currently marketed PD-1 and PD-L1 antibodies with a half-life that supports sustained >99% tumor target occupancy and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for possible enhanced efficacy in certain tumor types.

"This important issued U.S. patent for cosibelimab affords broad, foundational composition of matter protection for our antibody," said James F. Oliviero, President and CEO of Checkpoint. "We intend to continue expanding and fortifying our intellectual property portfolio for cosibelimab in the U.S. and internationally as we advance toward the completion of our clinical development program in CSCC, which initial indication for cosibelimab offers a $1-2 billion potential market opportunity."

About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma ("CSCC") is the second most common human cancer in the United States, with an estimated annual incidence of 700,000 cases. While most cases are localized tumors amenable to curative resection, approximately 8% of patients will experience a local recurrence, 5% of patients will develop nodal metastases, and an estimated 2% of patients will die from their disease. Ten-year survival rates are less than 20% for patients with regional lymph-node involvement. For those patients who develop distant metastases, the median survival time is estimated to be less than two years. In addition to being a life-threatening disease, CSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear.

About Cosibelimab
Cosibelimab (formerly referred to as CK-301) is a high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. PD-L1 is an immune-inhibitory checkpoint molecule expressed on epithelial and vascular endothelial cells, as well as by a number of immune cells, and is utilized by tumor cells as an immune escape mechanism. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies with a half-life that supports sustained >99% target tumor occupancy and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potential enhanced efficacy in certain tumor types.

On April 21, 2020 4SC AG (4SC, FSE Prime Standard: VSC) reported the Q1 Announcement 2020, presenting all material developments up to 31 March 2020 and the Company’s current outlook (Press release, 4SC, APR 21, 2020, View Source [SID1234556467]). The full communication is available for download on 4SC’s website.

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Jason Loveridge, Ph.D., CEO of 4SC, commented: "Whereas the Company had made good progress on both its development programs in Q1, including the FDA accepting our IND for the MERKLIN 2 study, most recently our team has been totally engaged with minimizing the impact of the global coronavirus pandemic on our Company and our clinical studies. Reflecting the sector more broadly, 4SC is also facing a temporary suspension of new recruitment in all of its active clinical studies and our clinical team is working overtime to ensure the safety of patients and the quality of data in our ongoing studies. 4SC is well financed and can, to a certain degree, weather the inevitable delay to study completions, however it is currently difficult to predict when study recruitment will return to normal. At this very challenging time our focus is first and foremost to ensure that patients in our active clinical studies are safe and may continue to receive medication, and to prepare as best we can for when circumstances will normalise".

Key highlight in Q1 2020 and beyond

FDA accepted Investigational New Drug (IND) application for domatinostat in combination with avelumab (Bavencio) in the MERKLIN 2 study.
2020 Business outlook

Domatinostat

Publish updated data from the SENSITIZE study in melanoma patients refractory to checkpoint blockade
Complete Phase IIa part of EMERGE study in micro-satellite stable gastrointestinal cancer
Initiate (first patient enrolled) of the Phase IIb part of the EMERGE study
Initiate the MERKLIN 2 study in Merkel cell carcinoma patients who are refractory to checkpoint blockade
Recruitment of the DONIMI study of domatinostat in the neoadjuvant setting in melanoma
Resminostat

Advance recruitment in the pivotal RESMAIN study so as to see the 125 events required to unblind the study in 2021
Development of cash balance in Q1 2020 and financial forecast

As of 31 March 2020, 4SC holds cash balance/funds of €40.350 million as compared to €45.765 million as of 31 December 2019. The monthly use of cash from operations amounted to €1.677 million on average in the first quarter of 2020 (Q1 2019: €1.263 million) and was below the range of €2.2 million and €2.6 million forecast for 2020.

The increase in the monthly use of cash as compared to Q1 2019, and the decrease in cash balance/funds in the first quarter of 2020 as compared to the end of 2019, were both predominantly due to costs for the ongoing clinical studies RESMAIN and SENSITIZE and mainly a result of the expansion of clinical programs for domatinostat, especially for the preparation of the clinical activities for the MERKLIN 2 study.

The Management Board of 4SC believes that the funds should be sufficient to finance 4SC into the second half of 2021.

On April 21, 2020 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) reported the recent allowances of 4 new different US and international patents concerning the Company’s prostate enlargement and prostate cancer treatments (Press release, Nymox, APR 21, 2020, View Source [SID1234556462]). The new US and international patents that have been allowed are further expansions of Nymox’s intellectual property covering the Company’s prostate treatment technologies.

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Nymox CEO, Dr Paul Averback stated, "Intellectual property is one of the backbones of the biopharmaceutical industry. We are therefore very pleased to report that another 4 patents have recently been allowed. During the past year a total of 10 new patents have been allowed which adds to the Company’s very strong intellectual property position for the future. Nymox continues with intensive work to maximize our IP portfolio for the long-term value and strength of the Company’s proprietary foundations."

Dr. Averback added, "Operationally at the present time, our employees are doing very well and are following the prescribed guidelines in their area, including working remotely, where necessary. On a different note, we are also extremely pleased with the reactions and feedback we are receiving from multiple sources with regard to the recent (Feb 2020) peer review journal article in the World Journal of Urology (View Source) documenting the very promising clinical results of Fexapotide Triflutate in treating men with early prostate cancer. We look forward to advancing this program into pivotal registrational trials."

The recent peer review publication is entitled "Prospective Evaluation of Fexapotide Triflutate Injection Treatment of Grade Group 1 Prostate Cancer: Four Year Results". The authors are Neal Shore, Myrtle Beach, SC; Steven A. Kaplan, New York, NY; Ronald Tutrone, Baltimore, MD; Richard Levin, Towson, MD; James Bailen, Louisville, KY; Alan Hay, Salem, OR; Susan Kalota, Tucson, AZ; Mohamed Bidair, San Diego, CA; Sheldon Freedman, Las Vegas, NV; Kenneth Goldberg, Lewisville, TX; Frederick Snoy, Albuquerque, NM; Jonathan I. Epstein, Baltimore, MD.

The Fexapotide (FT) prostate cancer study was started in 2012 and enrolled 147 men with localized Gleason Grade 6 T1c prostate cancer at 28 U.S. clinical investigation sites. Patients were followed with clinical and laboratory evaluations and regular periodic prostate biopsies for up to 5 years. Patients randomized to FT were treated with a single one-time targeted injection of FT, either 2.5mg or 15mg. Statistical comparisons were made over time of the proportions of subjects and untreated controls who progressed to higher Gleason grade and/or invasive treatments instituted with prostatectomy, radiotherapy, or chemotherapy. Important clinical highlights from the study include:

FT treatment reduced cancer progression (-67.7%) compared to controls (3 years, FT 15mg, p<.02, pooled FT p=.0265).
FT treatment group had reduced (-54.7%) incidence of surgery, radiotherapy or chemotherapy (4 years, FT 15mg p<.02; pooled FT p=.0374).
At 4 years the incidence of surgery, radiotherapy or chemotherapy with increased Gleason grade was significantly reduced (FT 15mg -73.3% p=.0059, pooled FT p=.0064).
Results for the high dose (FT 15mg) were superior to the lower dose (FT 2.5mg). Safety data showed no serious adverse events related to FT during the study.
FT is a pro-apoptotic proprietary drug which promotes natural programmed cell death (apoptosis) in prostatic glandular cells which compose the prostate cancer. FT has been safely administered to men in clinical trials in the U.S. involving over 1700 patients and controls treated for BPH or prostate cancer. FT has completed Phase 3 studies for BPH and further studies of FT for prostate cancer are planned in the near future.

On April 21, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported an update on the ongoing development of its product candidates, eftilagimod alpha ("efti" or "IMP321") and IMP761, as well as its response to the COVID-19 pandemic and its potential business impact (Press release, Immutep, APR 21, 2020, View Source [SID1234556461]).

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COVID-19 update

Immutep has welcomed recent guidance from the United States Food and Drug Administration ("FDA"), European Medicines Agency ("EMA") and other regulators on how to continue ongoing clinical trials during the COVID-19 pandemic. Cancer patients have been recognised by regulators as at risk and vulnerable to COVID-19 infection due to their weakened immune system. The FDA and other regulators are actively helping trial sponsors and hospitals continue critical clinical trials through the pandemic.

For Immutep, the safety and wellbeing of its clinical trial participants and investigators are its absolute priority. The Company is working closely with the clinical sites and regulators to monitor the situation, with the impact to date on treatment of patients being limited. Immutep also continues to work with its Clinical Research Organisation (CRO) partners to verify data remotely and review clinical trial processes according to the new guidance.

The Company anticipates that trial recruitment may slow down for its two actively recruiting trials, TACTI-002 and INSIGHT-004 over the coming months, due to the closure of hospitals in certain countries that have been most affected, such as Spain and the United Kingdom. However, INSIGHT has already recruited 91% of total patients and TACTI-002 has recruited 70% of total patients. Both its AIPAC and TACTI-mel trials are fully recruited.

Immutep is also implementing strategies to account for any impact of the pandemic on its ongoing trial data, related to potential patient infection. These strategies are under constant re-evaluation. As COVID-19 response restrictions are lifted, the Company will conduct an impact analysis to evaluate the overall effects of the pandemic.

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

LOGO

The Company’s own operations are minimally affected with increased home office work and less travel for the staff.

Eftilagimod alpha Clinical Update

TACTI-002-Phase II clinical trial

In mid-February, Immutep reported highly encouraging first data from its ongoing TACTI-002 study of efti in combination with pembrolizumab, an anti-PD-1 therapy. The data showed an Overall Response Rate (ORR)of 47% for patients in Part A, first line non-small cell lung cancer (NSCLC) patients who are receiving the combination treatment of efti with pembrolizumab. This compared very favorably to patients in Part A who are receiving pembrolizumab monotherapy and reported an initial ORR of approximately just 20%.

Trial recruitment continues to progress well, with 76 patients out of up to 109 already enrolled at 12 clinical sites across Australia, Europe, the UK and US. Details of recruitment for each Part are below.

Study—Part* Stage 1 (N)
Actual/target Stage 2 (N)
target
Part A—1st line NSCLC

17/17 17/19
Part B—2nd line NSCLC

18/23 -/13
Part C—2nd line met. HNSCC

18/18 6/19
Immutep was selected to provide a poster short talk presentation of new TACTI-002 data as part of the high- impact paper presentation program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, scheduled for 27 and 28 April. In addition, further data will be reported throughout 2020.

AIPAC-Phase IIb clinical trial

In March 2020, Immutep reported first results from its randomised, placebo controlled AIPAC trial in metastatic breast cancer. Patients receiving efti showed a positive trend in Progression Free Survival (PFS) rate at the 6-month landmark, with 63% of those who received paclitaxel plus efti being progression-free. This compared favourably to 54% of patients who received paclitaxel plus placebo. The ORR in the efti group was 48.3%, compared to 38.4% in the placebo group.

In addition, analysis on the trial subgroups showed that patients with a low monocyte count at baseline received a remarkable benefit from efti, with a median PFS of 7.29 months, compared to just 5.45 months in the placebo group (Hazard Ratio 0.61). Similarly, patients with a more aggressive, more immunogenic luminal B type also benefitted from efti with a median PFS of 7.29 months, compared to just 5.45 months in the placebo group (Hazard Ratio 0.65). Patients with lower general performance status at baseline also had a median PFS of 7.13 months compared to of 6.67 months in the placebo group (Hazard Ratio 0.76). These interesting subgroups are being discussed with the Company’s clinical advisory board as well as other partners and will be investigated further.

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

LOGO

Further building upon efti’s strong safety profile to date, the combination of efti and paclitaxel chemotherapy was overall safe and well tolerated. For further information please also view the webcast available at www.immutep.com.

Immutep expects to report Overall Survival (OS) and immuno-monitoring results from AIPAC later in 2020. Together with the already reported data, this will inform the Company’s future strategy for efti in metastatic breast carcinoma.

In early March 2020, Immutep received approval for its second Investigational New Drug ("IND") application from the United States FDA for efti. The IND enables the Company to initiate a clinical study in metastatic breast cancer patients. It also enables Immutep to further interact with the FDA regarding the use of efti in metastatic breast cancer.

INSIGHT-004 -Phase I clinical trial

Patient recruitment is continuing for Cohort 2 (30 mg efti) of the INSIGHT-004 study with 5 out of 6 patients participating. Cohort 1 is already fully recruited, bringing total recruitment to 11 out of 12 patients. As previously reported, the study is showing encouraging, positive initial activity.

The INSIGHT-004 is being conducted as the 4th arm of the INSIGHT trial and evaluates the combination of efti with avelumab in 12 patients with advanced solid malignancies.

TACTI-mel-Phase I clinical trial

Immutep is preparing a clinical study report for its TACTI-mel trial which reported positive final efficacy data in late 2019. The study showed deep and durable responses to the combination of efti and pembrolizumab in patients with metastatic melanoma. 12 patients (50%) reported a decrease of ³ 75% in the target lesions and 9 patients (38%) were treated for ³ 12 months.

IMP761 Preclinical Update

Since the end of the quarter, Immutep has reported significant progress in the cell line development of its IMP761 immunosuppressive product candidate. A pharmaceutical-grade, stable CHO cell line has been developed that produces significantly high product yields of IMP761. Immutep will complete its preparations for the Good Manufacturing Practice (GMP) process compliance development phase, ahead of potential clinical testing of the compound in autoimmune disease.

Partner Updates

EOC Pharma

Following the recent APIAC results, Immutep discussed the analysis of the reported PFS data (including subgroup analysis) with its Chinese partner for efti, EOC Pharma. Subsequently, EOC confirmed it plans to continue advancing efti (designated as EOC202 in China) in metastatic breast cancer.

Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000

ABN: 90 009 237 889

CYTLIMIC

At the end of the quarter, Immutep’s partner, CYTLIMIC reported positive results from its YNP01 phase I clinical trial which is evaluating the combination immunotherapy of a HSP70 derived peptide, a GPC3 derived peptide, Immutep’s IMP321 (efti) and Hiltonol in patients with advanced or metastatic solid cancer.

The results showed that approximately 70% of patients showed an immune response to each peptide. Further notable results were observed at the recommended dose (which has been adopted in CYTLIMIC’s Investigator-Initiated Phase I Trial CRESCENT1), including a significant reduction of lymphocyte population expressing an exhaustion marker in the peripheral blood and an overall survival of 18 months or more in 5 out of 11 patients.

The results were published in the scientific peer-reviewed journal, Cancer Immunology, Immunotherapy.

Financials

Cash receipts for the quarter were $0.22 million, compared to $7.28 million in Q2 FY2020. Q2 FY2020 was boosted by a milestone payment of £4 million from GSK related to the first patient being dosed in GSK’S Phase II clinical trial evaluating GSK2831781 in ulcerative colitis.

The net cash used in G&A activities in the quarter was $0.49 million compared to $1.43 million in Q2 FY2020. The decrease reflected a return to normalised levels, after the Company prepaid some annual corporate expenses related to the 2020 calendar year in Q2. G&A costs for the quarter includes $136K in payment of Non-Executive Director’s fees and Executive Director’s salary.

Total net cash outflows related to operating activities in the quarter was $6.09 million. In comparison, total net cash inflows in Q2 FY2020 were $1.22 million.

The net cash used in Research and Development activities in the last quarter was $4.71 million, compared to $6.19 million in Q2 FY2020. R&D expenditure is expected to continue to decline further over the remaining three quarters of this calendar year as almost all patients in the AIPAC Phase IIb clinical trial have completed the treatment and moved into the follow-up phase.

The cash balance as at 31 March 2020 was $16.1 million compared to a balance of $20.5 million as at 31 December 2019. Immutep’s cash position gives the Company an expected cash runway beyond multiple upcoming data catalysts in 2020 and into the beginning of CY 2021.

A copy of the Appendix 4C – Quarterly Cash Flow Report for the quarter is attached.